Healthy, Caffeine
Conditions
Keywords
Energy Drink
Brief summary
The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.
Interventions
OTHEREnergy Drink
Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed
OTHERPlacebo Drink
Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 18 years of age and older. * Healthy subjects without known cardiovascular disease and thyroid disease. * Subjects who are on no medications (except oral contraceptive pill). * Nonsmokers. * No prior history of caffeine sensitivity or allergy.
Exclusion criteria
* Subjects with known cardiovascular or thyroid disease. * Subjects currently taking medications other than oral contraceptive pill. * Smokers. * Prior history of caffeine sensitivity or allergy. * Pregnancy. * Subjects who regularly consume energy drinks. * Subjects who typically go to sleep after midnight. * Subjects who traveled across 2 time zones in the last 7 days. * Shift workers. * Subjects who have or are suspected to have sleep apnea. * Subjects who have a body mass index \> 35kg/m\^2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular arrhythmias | Baseline, approximately 1 hour prior to energy drink consumption | Frequency of ectopic ventricular beats |
| Atrial arrhythmias | Baseline, approximately 1 hour prior to energy drink consumption | Frequency of ectopic atrial beats |
| Changes in sleep efficiency | Throughout duration of sleep on both nights (night 1 and night 2) | Time asleep / time in bed |
| Changes in sleep continuity | Throughout duration of sleep on both nights (night 1 and night 2) | Frequency of wakefulness after sleep initiation |
| Changes in sleep architecture | Throughout duration of sleep on both nights (night 1 and night 2) | Time spent in each stage of sleep |
| QT segment | Baseline, approximately 1 hour prior to energy drink consumption | QT duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sympathetic activation quantified by urine dopamine | Approximately 24 hours | Total urine dopamine secretion |
| Sympathetic activation quantified by urine epinephrine | Approximately 24 hours | Total urine epinephrine secretion |
| Sympathetic activation quantified by changes in plasma norepinephrine | Baseline and AM of day 2 | Plasma norepinephrine while supine |
| Sympathetic activation quantified by changes in plasma epinephrine | Baseline and AM of day 2 | Plasma epinephrine while supine |
| Sympathetic activation quantified by changes in plasma dopamine | Baseline and AM of day 2 | Plasma dopamine while supine |
| Sympathetic activation quantified by urine norepinephrine | Approximately 24 hours | Total urine norepinephrine secretion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in resting heart rate | Baseline and AM of day 2 | Seated heart rate |
| Changes in resting blood pressure | Baseline and AM of day 2 | Seated systolic and diastolic blood pressure |
Countries
United States
Outcome results
None listed